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The DePuy Anatomic Locked Plating System Extra Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and nonunions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.

The Anatomic Locked Plating System Extra Long Plate Line Extension offers various longer length anatomically contoured plates for use with non-locking, locking and variable angle screws. With conventional nonlocking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate/screw construct provides stability even in osteopenic bone where screw purchase can be more difficult. These posterior lateral plates will be available in 210mm and 250mm lengths.

The provided document is a 510(k) summary for the DePuy Anatomic Locked Plating System Extra Long Plate Line Extension. It outlines the device's characteristics, its substantial equivalence to predicate devices, and its intended use.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" and "validation in cadaveric models" but does not provide specific numbers for the plates tested or the number of cadavers used.
• Data Provenance: The testing was likely conducted in a controlled laboratory environment by the manufacturer (DePuy Orthopaedics, Inc. in Warsaw, IN). The data is prospective in the sense that it was generated specifically for this submission to demonstrate equivalence. The country of origin for the data is implicitly the USA given the address of the submitting company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. For a medical device like a bone plate, "ground truth" typically refers to established biomechanical standards and measurements, and potentially expert evaluation of surgical construct stability in cadaveric models. The document doesn't detail who performed these evaluations or their qualifications.

4. Adjudication method for the test set

• This information is not provided. Given the nature of bench testing and cadaveric validation for a bone plate, it's less likely to involve a human adjudication process in the same way an imaging AI might. Instead, performance is measured against established engineering and biomechanical specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. This device is a mechanical implant (bone plate), and its effectiveness is determined through mechanical testing and biological modeling, not human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable to the device described. This device is a bone plate, not an algorithm or a system that operates with or without human-in-the-loop performance. Its performance is entirely "standalone" in the sense that its mechanical properties are inherent to the device itself.

7. The type of ground truth used

• The ground truth for this device's performance relies on established biomechanical engineering standards and specifications. This includes:
  • Mechanical Load and Bend Testing: Measuring the plate's resistance to deformation and failure under various forces, simulating physiological loads.
  • Cadaveric Model Validation: Assessing the plate's performance and stability when implanted in human cadaveric bone, simulating surgical application. This type of "ground truth" in this context is based on in vitro and ex vivo experimental data, comparing its performance directly to the legally marketed predicate devices.

8. The sample size for the training set

• This question is not applicable to the device described. There is no mention of "training set" as this is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

• This question is not applicable for the reasons stated above (no training set for a physical implantable device).

In summary, the substantial equivalence of the DePuy Anatomic Locked Plating System Extra Long Plate Line Extension was established through direct comparison to predicate devices using bench testing (load and bend testing) and cadaveric validation. The acceptance criteria, while not explicitly detailed in quantitative terms in this summary, were met by demonstrating equivalent performance to the predicate devices in these tests.

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The DePuy Anatomic Locked Plating System Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.

The Anatomic Locked Plating System Long Plate Line Extension offers various longer length anatomically contoured plates for use with nonlocking, locking and variable angle screws. With conventional non-locking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate / screw construct provides stability even in osteopenic bone where screw purchase can be more difficult.

The supplied text describes a 510(k) premarket notification for a medical device called the "DePuy Anatomic Locked Plating System Long Plate Line Extension." However, it does not contain the specific details required to complete all sections of your request concerning acceptance criteria and a study that proves the device meets them in the context of an AI/human reader study.

Based on the provided text, here's what can be extracted:

• Device Type: This is a physical bone fixation device (plate, fixation, bone long plate line extension), not a software or AI-driven diagnostic tool. Therefore, many of the questions related to AI performance, human readers, ground truth for algorithms, etc., are not applicable to this particular submission.
• Study Type: The device's equivalency was established through bench testing.

Here's a breakdown of the information that can be answered and what cannot be answered from the provided text, along with explanations:

Acceptance Criteria and Device Performance Study for DePuy Anatomic Locked Plating System Long Plate Line Extension

1. Table of Acceptance Criteria and Reported Device Performance

• Explanation: The document states that the device successfully met "pre-determined acceptance criteria" through "load and bend testing." However, the specific numerical or qualitative criteria (e.g., maximum deflection, ultimate load, fatigue cycles) are not detailed in this summary. These would typically be specified in the full test protocols and reports, which are not included here.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. This typically refers to the number of physical plates tested in bench studies.
• Data Provenance: Not applicable in the conventional sense (e.g., country of origin for clinical data). The data comes from bench testing performed by the manufacturer, DePuy Orthopaedics, Inc., at their facilities (indicated by the submission address in Warsaw, IN).
• Retrospective/Prospective: Not applicable as it's not a clinical study. It's a laboratory-based, prospective testing of new device samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a hardware device tested via physical bench testing, not an AI or diagnostic device that requires expert review for ground truth establishment.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI studies or clinical trials, not for bench testing of mechanical properties. The "ground truth" here is the physical performance measured against engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not done. This type of study is relevant for diagnostic devices (e.g., imaging software) where human readers interpret medical images or data, and an AI's impact on their performance is evaluated. This device is a bone fixation plate.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Not Applicable. This question pertains to AI algorithms. The DePuy Anatomic Locked Plating System is a physical implant.

7. Type of Ground Truth Used

• Engineering Specifications / Predicate Device Performance. For mechanical devices, the "ground truth" in performance testing is typically defined by established engineering standards (e.g., ASTM, ISO) or, in the case of 510(k) submissions, by demonstrating equivalence to the performance of legally marketed predicate devices. The document implies that the acceptance criteria were derived from the performance of the predicate devices (K082300 and K072083).

8. Sample Size for the Training Set

• Not Applicable. This device uses physical bench testing for performance demonstration, not a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As above, no training set in the machine learning sense was used. The product's design and manufacturing processes are likely informed by engineering principles, material science, and clinical needs, but not data-driven "ground truth" for a training set.

In summary, the provided document is a 510(k) summary for a mechanical medical device (bone plate). Many of your questions are tailored towards AI/software medical devices or clinical studies, which are not applicable to this submission. The performance demonstration was entirely based on bench testing to show equivalence to predicate devices in terms of mechanical properties.

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